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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

2017 年 04 月 23 日 8:00 上午 - 2017 年 04 月 23 日 5:00 下午

1750 Rockville Pike, , Rockville, MD 20852 , USA

Course: Regulatory CMC Training - The Basics to Prepare for the CMC Workshop

概览

Short Course* Registration: 7:00AM-5:00PM

This course will cover the basics of regulatory CMC topics that will be covered during the Workshop at a higher level. It will allow you to gain a better understanding about regulatory applications in the US and abroad, stability requirements, and inspections. The course will jumpstart your knowledge to allow you to make the most of your time during the full Workshop.
Instructors

Elaine Morefield, PhD
Vice President Regulatory Affairs
VaxForm, LLC.

Lin-Jau (Christine) Wu Anderson, MS
Senior Research Scientist, Global Regulatory, Chemistry, Manufacturing and Control
Eli Lilly and Company

*Short Courses are not included in the forum registration and require a separate fee.

Return to the CMC Workshop

学习目标

At the conclusion of this Short Course, participants should be able to:

  • Become familiar with the basics of CMC
  • Increase level of understanding of CMC regulations to facilitate better understanding of the topics in the CMC Workshop
  • Hone skills in the CMC regulatory area to enhance work performance

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